U.S. patent application number 15/142887 was filed with the patent office on 2017-11-02 for container holder assembly.
The applicant listed for this patent is SHL Group AB. Invention is credited to Gunnar Elmen, Per Klintenstedt, Anders Wieselblad.
Application Number | 20170312173 15/142887 |
Document ID | / |
Family ID | 58461293 |
Filed Date | 2017-11-02 |
United States Patent
Application |
20170312173 |
Kind Code |
A1 |
Klintenstedt; Per ; et
al. |
November 2, 2017 |
Container Holder Assembly
Abstract
According to aspects of the present disclosure, a retaining
apparatus for use with a medicament delivery device is provided.
The medicament delivery device includes a container holder assembly
and an actuator assembly. The container holder assembly is
configured to receive a container containing a medicament. The
container holder assembly is configured to couple to the actuator
assembly. The actuator assembly includes a plunger rod for engaging
a stopper in the container. The retaining apparatus includes a
plunger lock, a retaining member, and a biasing member. The plunger
lock is seated within a proximal end of the actuator assembly, and
secures the plunger rod. The retaining member is seated within the
plunger lock. The biasing member is secured between the proximal
end of the actuator assembly and the retaining member. The
retaining member is biased in a proximal direction by the biasing
member.
Inventors: |
Klintenstedt; Per; (Nacka
Strand, SE) ; Wieselblad; Anders; (Stockholm, SE)
; Elmen; Gunnar; (Huddinge, SE) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
SHL Group AB |
Nacka Strand |
|
SE |
|
|
Family ID: |
58461293 |
Appl. No.: |
15/142887 |
Filed: |
April 29, 2016 |
Current U.S.
Class: |
1/1 |
Current CPC
Class: |
A61M 5/2033 20130101;
A61J 1/16 20130101; A61M 5/008 20130101; A61M 5/31501 20130101;
A61M 5/315 20130101; A61M 2005/31508 20130101 |
International
Class: |
A61J 1/16 20060101
A61J001/16; F16M 13/02 20060101 F16M013/02; A61M 5/00 20060101
A61M005/00 |
Claims
1. A retaining apparatus for use with a medicament delivery device,
the medicament delivery device comprising a container holder
assembly and an actuator assembly, the container holder assembly
configured to receive a container containing a medicament, the
container holder assembly configured to couple to the actuator
assembly, wherein the actuator assembly comprises a plunger rod for
engaging a stopper in the container, the retaining apparatus
comprising: a plunger lock seated within a proximal end of the
actuator assembly, the plunger lock securing the plunger rod; a
retaining member seated within the plunger lock; and a biasing
member secured between the proximal end of the actuator assembly
and the retaining member; wherein the retaining member is biased in
a proximal direction by the biasing member.
2. The retaining apparatus of claim 1, wherein the plunger lock
defines an internal cavity.
3. The retaining apparatus of claim 2, wherein the retaining member
is slidably biased within the internal cavity of the plunger
lock.
4. The retaining apparatus of claim 1, wherein the retaining member
comprises a cylindrical structure, and wherein the cylindrical
structure comprises a front end and a back end.
5. The retaining apparatus of claim 4, wherein and back end of the
cylindrical structure comprises an outer wall and an inner wall,
and wherein the outer wall and the inner wall of the cylindrical
structure define a first annular cavity.
6. The retaining apparatus of claim 5, wherein the first annular
cavity defined between the outer wall and the inner wall of the
retaining member further defines a first annular cavity end
wall.
7. The retaining apparatus of claim 6, wherein the biasing member
resides within the first annular cavity of the retaining member and
acts upon the first annular cavity end wall to bias the retaining
member in the proximal direction.
8. The retaining apparatus of claim 7, further comprising: a
supporting washer such that the biasing member resides in a biased
state between a front side of the supporting washer and the first
annular cavity end wall of the retaining member.
9. The retaining apparatus of claim 3, wherein the front end of the
retaining member comprises a cylindrical structure that defines a
second annular cavity, the second annular cavity comprising a
second end wall that is configured to receive a distal end of a
container contained within a container holder assembly.
10. The retaining apparatus of claim 1, wherein the plunger lock is
configured for releasable attachment to a distal end of the
container holder assembly.
11. The retaining apparatus of claim 10, wherein the retaining
member is configured for releasable attachment to a distal end of a
container contained within the container holder assembly such that
the distal end of the container is resiliently pressed against the
container holder assembly.
12. The apparatus of claim 1, wherein the plunger lock is fixedly
attached to a housing of the actuator assembly.
13. The apparatus of claim 1, wherein the retaining member
comprises a plurality of spacers provided along an outer wall of
the retaining member.
14. The apparatus of claim 13, wherein the plurality of spacers are
equally spaced along a back end of the retaining member.
15. The apparatus of claim 13, wherein the plurality of spacers are
configured to engage a plurality of tracks defined by the plunger
lock.
16. The apparatus of claim 15, wherein the plurality of spacers are
configured to slidably engage the plurality of tracks defined by
the plunger lock.
17. The apparatus of claim 15, wherein the plurality of spacers are
configured to allow relative movement of the retaining member with
respect to the plunger lock.
18. The apparatus of claim 1, wherein the retaining member is
rotatably fixed within the plunger lock.
19. The apparatus of claim 1, wherein the plunger rod passes
through an axially aligned aperture defined by the retaining
member.
20. The apparatus of claim 1, wherein the plunger rod passes
through an axially aligned opening defined by the plunger lock.
Description
BACKGROUND
[0001] A medicament delivery device, such as an injector, is often
arranged with a container holder to allow operations to be carried
out on the container, for instance displacement within the injector
housing during skin penetration, expulsion of medicament by a
plunger acting on the stopper in the container, penetration of the
septum using a needle and replacement of container. Because of
tolerances, manufactured containers vary in size, which may result
in the position of the container within the holder being somewhat
affected during handling of the device. For instance, displacement
of the container may occur as a result of penetrating the septum of
the container with a needle or by sudden impact forces to the
housing of the device. If the container is not exactly positioned
in relation to the holder, the stroke length of the plunger
rod--and consequently the dosage set by the user or the
manufacturer of the device--will not be exactly correlated to the
actual position of the container, resulting in the wrong dose being
delivered. Also, movement of the container within the holder may
lead to a higher risk of breaking the container due to impact
forces between the holder and the container.
SUMMARY
[0002] According to aspects of the present disclosure, a retaining
apparatus for use with a medicament delivery device is provided.
The medicament delivery device includes a container holder assembly
and an actuator assembly. The container holder assembly is
configured to receive a container containing a medicament. The
container holder assembly is configured to couple to the actuator
assembly. The actuator assembly includes a plunger rod for engaging
a stopper in the container. The retaining apparatus includes a
plunger lock, a retaining member, and a biasing member. The plunger
lock is seated within a proximal end of the actuator assembly, and
secures the plunger rod. The retaining member is seated within the
plunger lock. The biasing member is secured between the proximal
end of the actuator assembly and the retaining member. The
retaining member is biased in a proximal direction by the biasing
member.
[0003] The present disclosure thus provides a device that can
securely keep the container in a predetermined position in relation
to the container holder in order to be able to deliver a set dose
in a safe and reliable way without damaging the holder or the
container. With regard to cost and complexity the device can be
easy to manufacture and to implement. The resulting device can also
be simple and intuitive for the end user to operate.
[0004] These as well as other aspects, advantages, and alternatives
will become apparent to those of ordinary skill in the art by
reading the following detailed description with reference where
appropriate to the accompanying drawings. Further, it should be
understood that the description provided in this summary section
and elsewhere in this document is intended to illustrate the
claimed subject matter by way of example and not by way of
limitation.
BRIEF DESCRIPTION OF THE DRAWINGS
[0005] In the following description of embodiments of the present
disclosure, reference will be made to the accompanying drawings of
which:
[0006] FIG. 1 is a perspective view of a container holder assembly
and container in an assembled state according to aspects of the
present disclosure.
[0007] FIG. 2 is a perspective view showing a container outside the
container holder assembly.
[0008] FIG. 3 is a perspective view showing the container holder
assembly in a disassembled state.
[0009] FIG. 4 is a cross-sectional view of the container holder
assembly and the container of FIG. 1.
[0010] FIG. 5 is a perspective view of a medicament delivery device
according to additional aspects of the present disclosure.
[0011] FIG. 6 is a cross-sectional view of the medicament delivery
device of FIG. 5.
[0012] FIG. 7 is an exploded perspective view of the medicament
delivery device of FIG. 5.
[0013] FIGS. 8A-8B are perspective views of a medicament delivery
device in a disassembled state according to additional aspects of
the present disclosure.
[0014] FIGS. 9A-9B are perspective views of the medicament delivery
device of FIGS. 8A-8B in an assembled state.
[0015] FIG. 10 is an exploded perspective view of a container
holder assembly according to aspects of the present disclosure.
[0016] FIG. 11 is a perspective view of the container holder
assembly of FIG. 10.
[0017] FIG. 12 is an exploded perspective view of an actuator
assembly according to aspects of the present disclosure.
[0018] FIG. 13 is a perspective view of a plunger lock according to
aspects of the present disclosure.
[0019] FIGS. 14A-14B are perspective views of a retaining member
according to aspects of the present disclosure.
[0020] FIG. 14C is a cross-sectional view of the retaining member
depicted in FIG. 14A.
[0021] FIG. 15 is a cross-sectional view of a proximal portion of
the actuator assembly.
[0022] FIG. 16A is a cross-sectional view of the container holder
assembly initially engaging the actuator assembly according to
aspects of the present disclosure.
[0023] FIG. 16B is a cross-sectional view of the container holder
assembly coupled to the actuator assembly according to aspects of
the present disclosure.
DETAILED DESCRIPTION
[0024] Embodiments of the present disclosure will now be described
in detail. As should be noted in the present application, when the
term "distal part/end" is used, this refers to the part/end of the
delivery device, or the parts/ends of the members thereof, which
is/are located the furthest away from the medicament delivery site
of the patient. Correspondingly, when the term "proximal part/end"
is used, this refers to the part/end of the delivery device, or the
parts/ends of the members thereof, which, is/are located closest to
the medicament delivery site of the patient.
[0025] According to an aspect of the present disclosure, a
container holder assembly is provided for use in a medicament
delivery device, which container holder assembly comprises a
tubular body elongated in an axial direction, said tubular body
having a proximal end and an opposite distal end. A retaining
member is releasably arranged to said tubular body for securing an
elongated container placed inside the tubular body. The retaining
member comprises a resilient structure that is capable of exerting
an axial force on said container in said tubular body for holding
the container in a fixed position inside the tubular body and
thereby avoiding breakage or displacement of the container.
[0026] FIGS. 1-4 depict an example container holder assembly
according to such aspects of the present disclosure. The example
shown in the FIGS. 1-4 is a container holder assembly for
medicament delivery devices but is not restricted to it. FIG. 1 is
a perspective view of exemplary components of such a container
holder assembly. A tubular body 10, such as a container holder, is
elongated along an axis X with a closed proximal end and an open
distal end for receiving a container 20. In order to secure the
container 20 inside the tubular body 10, a retaining member 30 is
arranged to the container holder for gripping the container and
resiliently urging it into abutment with a stop surface inside the
tubular body 10.
[0027] The exemplary embodiment disclosed in FIG. 1 shows the
retaining member 30 arranged at the open, distal end of the tubular
body 10, gripping the distal end of the container 20. The present
disclosure is not restricted to this arrangement however. The
container holder assembly may be may be constructed in many
different ways without departing from the concept of the present
disclosure. The resilient structure of the retaining member 30 will
be explained below.
[0028] The tubular body 10 may also be arranged with radially
protruding elements 16 arranged to key the container holder
assembly to a certain type of delivery device in order to prevent
the use of the assembly in a device that it is not intended
for.
[0029] A proximal part of the tubular body 10 may be arranged with
an interface 12, such as threads, for connecting a delivery member
(not shown). The delivery member may be a needle, a nozzle, a mouth
piece, or the like.
[0030] FIG. 2 shows the assembly in a semi-assembled state, wherein
the container 20 has not yet been loaded in the tubular body 10 and
wherein the retaining member 30 is loosely arranged to the tubular
body 10, prepared for receiving the container 20. The physical
dimensions of the assembly are adapted to a certain type of
container but the present disclosure allows for large dimensional
tolerances of the containers thanks to the resilient structure of
the retaining member 30, which holds the container in a
predetermined position inside the container holder despite
variations in physical dimensions of the container.
[0031] An exemplary container 20, as show in FIG. 2, may contain
medicament and is tubular and made of glass. A proximal end
typically has a shoulder portion 26 connecting the tubular part
with a neck portion and a cap 24. The cap comprises a septum that
seals the proximal end of the container. The distal end of the
container is sealed by an axially movable stopper 22.
[0032] FIG. 3 depicts a perspective view showing the container
holder assembly in a disassembled state. The retaining member 30,
which is here shown outside the tubular body 10, comprises a
resilient structure that allows the body of the retaining member to
be flexible in the axial direction, i.e. to stretch or to compress,
so that the proximal end and the distal end of the retaining member
may be axially displaced with regard to each other. The resilient
structure 36 is achieved by forming circumferentially elongated
cut-outs, or slits, in the tubular wall of the retaining member 30.
The slits are arranged in at least two parallel circumferentially
aligned rows, wherein a space between any two slits of one row is
aligned with the centre of a slit of an adjacent row.
[0033] At least two gripping means 34 are arranged on the distal
annular end surface of the retaining member 30. The gripping means
34 may be formed as distally protruding, inwardly curved hooks that
are able to flex radially outwards as the container 20 is pushed
inside the tubular body 10. Each gripping means is aligned with the
centre of one of the most distal slits.
[0034] The proximal portion of the retaining member 30 is arranged
with a first locking means 32 capable of mutual mechanical
connection with a second locking means 120 of the tubular body 10.
The first locking means 32 may be formed as at least two
protrusions, or guide knobs, that extend radially outwardly from
the outer circumferential surface of the retaining member 30,
whereas the second locking means 120 may be formed as a cut-out, or
guide track, that is able to guide a protrusion of the first
locking means 32 along the track as the first and second locking
means are axially rotated in relation to each other, i.e. in the
fashion of a bayonet connection. Each protrusion is aligned with
the centre of one of the most proximal slits.
[0035] The gripping means 34 are arranged to abut the distal annual
end surface of the container 20 when the container has been placed
in the tubular body 10 and the first and second locking means are
brought into locking position with each other (explained in detail
below).
[0036] The resiliency of the retaining member 30 of the exemplary
embodiment of FIG. 3 results from the careful alignment of the
slits, the gripping means 34 and the first locking means 32. For
best performance, the number of gripping means equals the number of
slits in the most distal row of slits and the number of first
locking means equals the number of slits in the most proximal row
of slits. Preferably, the number of slits in one row equals the
number of slits in each of the other rows. Most preferably, the
number of slits in one row equals two. To achieve good resiliency
it is also preferable that the circumferential length occupied by a
slit is significantly larger than the circumferential length
occupied by the space between two slits of any adjacent rows.
[0037] In a similar fashion, an end--preferably the distal end--of
the tubular body 10 may be arranged with a second resilient
structure 110. As the container holder assembly, with a container
inside, is inserted by a user in a delivery device by attaching the
tubular body to holding means (not shown) arranged at a proximal
receiving end of the device (not shown). The distal annular end
surface of the tubular body thereby comes into abutment with a
surface of the delivery device, forcing the second resilient
structure 110 to compress axially. The user may then attach a
delivery member to the interface 12 in order to use the device
[0038] FIG. 4 shows a cross-section of the exemplary embodiment of
the tubular body 10. The second locking means 120 (FIG. 2) may be
formed as a cut-out, or guide track, that is able to guide a
protrusion of the first locking means 32 along the track as the
first and second locking means are axially rotated in relation to
each other. The track has a distally directed opening 170 through
which the first locking means 32 of the retaining member 30 may be
inserted into the track. After insertion the first locking means is
in the initial position 140 of the second locking means. By
slightly rotating the tubular body 10 and the retaining member 30
with respect to each other, for instance by using a specialized
tool, the first locking means is forced past a first stopper 130a
arranged to prevent unintentional rotation of the locking means.
The first locking means is then in a loading position 150, as
depicted in FIG. 2. In the loading position 150 the container
holder assembly is ready for insertion of a container 20 into the
tubular body 10. As the container is pushed into the tubular body
the gripping means 34 flex radially outwards, snapping back as the
distal end of the container passes the gripping means. The
container is now loosely secured in the tubular body, resting with
its shoulder portion 26 against the inner annular ledge 190 of the
tubular body 10. The container will not fall out since the gripping
means 34 is blocking movement in the distal direction and the first
locking means 32 is confined between the first stopper 130a and a
second stopper 130b. However, in the loading position, the
retaining member still does not exert an axial force on the
container.
[0039] To achieve an object of the present disclosure, i.e. to fix
the container in an exact predetermined position in the tubular
body 10, an axial force can be exerted between the tubular body and
the container, such that they are pressed towards each other. In
the exemplary embodiment of FIG. 4 this is attained by further
rotation of the retaining member with regard to the tubular body.
When the first locking means 32 is forced past the second stopper
130b the track of the second locking means deviates from a
circumferential path to a circumferential/axial path, forcing the
proximal part, i.e. the first locking means and consequently the
whole the retaining member in a proximal, axial direction. Since
the gripping means 34 is arranged to abut the distal annular
surface of the container 20 and the container is hindered from
proximal displacement because it is resting with its shoulder
portion 26 in abutment with the inner annular ledge 190 of the
tubular body 10, the resilient structure 36 begins to stretch
axially in the proximal direction. The tensioned resilient
structure exerts an axial force such that the gripping means 34
urges the shoulder portion 26 of the container 20 and the inner
annular ledge 190 of the tubular body 10 against each other.
[0040] As the retaining member and the tubular body are further
rotated with regard to each other, the track of the second locking
means 120 eventually returns to a circumferentially aligned path.
The first locking means is forced past the third stopper 130c and
comes to rest in a holding position 160, abutting the distal
surface of the track due to the axial force exerted by the
resilient structure 36.
[0041] The overall pitch of the track of the second locking means
is carefully determined during manufacture of the assembly to
achieve a force that is strong enough to fix the container inside
the tubular body, regardless of the tolerances of the container
used, but at the same time to achieve a force that is not so strong
as to risk damaging the container.
[0042] Another parameter that may be used to calibrate the force
during manufacturing is the resiliency of the resilient structure
36. This may be varied, for instance by selecting an appropriate
number of rows of slits of the resilient structure, or by the
material chosen for the container holder assembly, or by the
thickness of the wall of the retaining member or the distance
between the rows of slits, etc.
[0043] Other designs of the locking means 32, 120 are also
conceivable, such as mutually engaging threads.
[0044] A second exemplary embodiment of the present disclosure is
shown in FIGS. 5-7. FIG. 5 is a perspective view of a medicament
delivery device 40 to which a container holder 10', comprising a
container (not shown), has been attached using retaining member
50.
[0045] FIG. 6 shows a cross-section of the connection between the
device 40 and the container holder 10' of FIG. 5. The retaining
member 50 is, in the exemplary embodiment shown, comprised of a
first part 50a, a second part 50b and a third part 50c that
together form an axially aligned annular housing with a
through-going axially aligned hole for accommodating the container
holder 10' with the container 20. The retaining member 50 also
houses a resilient structure 500 comprising at least one resilient
washer 56, and a spacer 52. If multiple resilient washers 56 are
used, at least one supporting washer 54 is positioned between them
in order to separate the resilient washers 56 from each other.
[0046] The third part 50c of the retaining member comprises
attachment means (not shown) on a distal circumferential surface
for mutually connecting with engagement means 44 on a proximal
circumferential surface of the delivery device 40. Various
solutions are conceivable for the mutual connection of the
retaining member and the delivery device, e.g. such as a threaded
connection or bayonet connection.
[0047] The retaining member 50 and its constituent components are
assembled during manufacturing and are designed for a predetermined
kind of container holder 10', which in turn is designed to hold a
predetermined kind of container 20. An object of the present
disclosure, however, is to allow large tolerances in the physical
dimensions of the container 20 without affecting the accuracy of
the dose delivery, i.e. by holding the container in a fixed
position in relation to the container holder, and without damaging
the container. This is achieved by resilient fixation of the
container in the holder.
[0048] The function of the retaining member 50 will now be
described in conjunction with FIG. 7, which is an exploded view of
the delivery device 40 and the container holder assembly, i.e. the
retaining member 50 and the container holder 10'. Also shown is an
inserted exploded image of the resilient structure 500 housed in
the resilient means 50.
[0049] The resiliency of the retaining member 50 is a function of
the stack of resilient washers 56. The washers may, for instance,
have a wavy shape that results in an axial restoring force if the
washers are compressed. Since the shape of the individual resilient
washers is identical a supporting washer 54 may be used to separate
them from each other. Otherwise, adjacently packed resilient
washers would result in much reduced flexibility.
[0050] When the delivery device is to be used a container is
inserted in the tubular body 10' by the distal end. At least two
radially inwardly protruding cut-outs in the form of flexible
tongues 195 are arranged in the circumferential wall of the tubular
body 10' to flex radially outwards as the cap 24 is pushed against
the tongues in order to let the container pass. Thereafter, the
tongues flex back inwards, preventing return-movement of the
container and securing it by its neck portion 28 (FIG. 6) inside
the tubular body 10' such that it cannot accidentally fall out
before the container holder assembly has been attached to the
delivery device 40. When the container is secured in the tubular
body, the distal end of the container still protrudes distally of
the tubular body, the function of which will be explained
below.
[0051] The tubular body 10' holding the container is then inserted
in the retaining member 50 from the distal side such that the
proximal surface of the circumferential flange 14' arranged at the
distal end of the tubular body comes to rest against the distal
surface of the annular spacer 52. The container holder assembly,
including the container, is subsequently attached to the proximal
end of the delivery device by the mutual connection described
above.
[0052] As the mutual connection of the container holder assembly
and the delivery device is tightened, such as by turning the
retaining member 50 in relation to the delivery device 40 for
mutually engaging threads or for operating a bayonet connection,
the protruding distal annular surface of the container abuts the
stopping element 42. The abutting function of the stopping element
could also be achieved by an integrated surface of the delivery
member 40 itself, such as a surface of the housing.
[0053] Further tightening of the connection results in compression
of the resilient washers 56 between the first part 50a and the
spacer 52 resting against the flange 14'. This leads to a restoring
axial force, arising from the compressed resilient washers 56, that
acts on the flange 14' to urge the tubular body 10' in the distal
direction. Since the container 20 abuts the stopping element 42,
the inner annular ledge 190' is brought into abutment with the
shoulder portion 26 of the container, forcing the container against
the stopping element 42. The force arising from the compression of
the resilient washers 56 thereby fixes the container with regard to
the tubular body 10' and the delivery device 40.
[0054] Referring now to FIGS. 8A-16B another example medicament
delivery device 200 is shown according to aspects of the present
disclosure. FIGS. 8A-8B depict perspective views of the medicament
delivery device 200 in a disassembled state. As shown in FIGS.
8A-8B, the medicament delivery device 200 includes a container
holder assembly 210, a container 220, and an actuator assembly 240.
The container 220 contains a medicament (e.g., a liquid contents).
The container holder assembly 210 includes a bore 214 for receiving
the container 220. The actuator assembly 240 removably couples with
the container holder assembly 210 and includes components that
facilitate delivering one or more doses of a medicament from the
container 220 to a patient. FIGS. 9A-9B depict perspective views of
the medicament delivery device 200 with the container 220 in the
container holder assembly 210 and the container holder assembly 210
coupled to the actuator assembly 240 (i.e., in an assembled
state).
[0055] To contain the medicament, the container 220 can have an
internal chamber 216 defined by elongated, hollow body 218 that is
fluidly sealed on a distal end 218A and a proximal end 218B (e.g.,
as described above with respect to container 20). For example, the
container 220 can be sealed by a cap 224 at the proximal end 218B.
At the distal end 218A, the container 220 is fluidly sealed with an
axially movable stopper 222 that engages an inner wall of the
container 220. As the stopper 222 moves axially toward the proximal
end 218B of the container 220, the stopper 222 pushes the
medicament contents through an opening in the proximal end 218B,
provided that the fluid seal (if included) on the proximal end 218B
has been pierced, breached, or opened.
[0056] As noted above, the container holder assembly 210 can be
removably coupled to the actuator assembly 240. For example, on an
exterior surface 226 of a proximal portion 228, the actuator
assembly 240 can include one or more tracks 230 that receive one or
more corresponding protrusions 234 on an inner surface 236 of a
distal portion 232 of the container holder assembly 210 (shown in
FIGS. 10-11). The track(s) 230 can receive the protrusion(s) 234
via a distally directed opening and then guide the protrusion(s)
234 distally along a circumference of the exterior surface 226. As
the container holder assembly 210 and the actuator assembly 240 are
rotated with respect to one another, the protrusion(s) 234 travel
along the track(s) 230 causing the container holder assembly 210 to
move distally towards the actuator assembly 240 due to a distally
directed pitch of the track(s) 230.
[0057] The container holder assembly 210 is further depicted in
FIGS. 10-11. FIG. 10 depicts an exploded view of the container
holder assembly 210. As shown in FIG. 10, the container holder
assembly 210 includes an inner housing 238, an outer housing 242,
and a cover 244. The inner housing 238 includes the bore 214 for
receiving the container 220. The bore 214 extends from an open
distal end 238A to an open proximal end 238B of the inner housing
238. The bore 214 may narrow at the proximal end 238B (e.g., at a
shoulder portion 225) so as to axially retain the container 220 in
the inner housing 238 at the proximal end 238B. Further, at the
proximal end 238B, the inner housing 238 includes an interface 212
(e.g., threads). The interface 212 is configured to couple the
inner housing 238 to a delivery member such as, for example, a
needle, a nozzle, a mouth piece, and/or the like.
[0058] At the distal end 238A, the inner housing 238 includes a
resilient structure 246. The resilient structure 246 includes one
or more apertures 248. The aperture(s) 248 allow the resilient
structure 246 to axially compress and/or stretch and, thus, provide
resiliency to the resilient structure 246. In an example, the
aperture(s) 248 of the resilient structure 246 can be formed as
slits arranged in a plurality of rows. For instance, the slits can
be arranged on the resilient structure 246 in a manner similar to
that described above with respect to the slits on the retaining
member 30 and the second resilient structure 110.
[0059] The outer housing 242 has an axial cavity 250 defined by the
inner surface 236, which extends between openings at a distal end
242A and a proximal end 242B of the outer housing 242. When the
container holder assembly 210 is assembled, the inner housing 238
is received in the cavity 250 of the outer housing 242. The outer
housing 242 can be coupled to the inner housing 238 by, for
example, a friction fit. As such, the cavity 250 can have a size
and shape corresponding to a size and shape of the inner housing
238. In other examples, the outer housing 242 can be coupled to the
inner housing 238 in additional or alternative ways (e.g., by
locking tabs, threads, adhesives, etc.).
[0060] The cover 244 can be removably coupled to the outer housing
242. For example, the cover 244 can couple to the outer housing 242
via friction-fit, snap-fit, locking tabs, corresponding detents and
recesses, etc. When coupled to the outer housing 242, the cover 244
can substantially enclose the inner housing 238 and the outer
housing 242. In this way, the cover 244 can protect the container
220 in the container holder assembly 210 from contamination when
not in use.
[0061] FIG. 11 depicts the container holder assembly 210 in the
assembled state. In FIG. 11, the cover 244 is shown in broken lines
to show the inner housing 238 and the outer housing 242 within the
cover 244. As shown in FIG. 11, the inner housing 238 is received
in the outer housing 242. The outer housing 242 further includes
one or more protrusions 234 extending from the inner surface 236 in
a distal portion of the outer housing 242. The protrusions 234 are
configured to engage with corresponding tracks 230 on the delivery
device 240, as described herein. At a proximal portion, the outer
housing 242 includes an outer surface 255 to which the cover 244
couples when the container holder 210 is received in an internal
cavity of the cover 244.
[0062] FIG. 12 depicts an exploded view of the actuator assembly
240. As shown in FIG. 12, the actuator assembly 240 includes a
housing 256, an actuator device 258, and a retainer assembly 260.
The housing 256 receives the actuator device 258 and the retainer
assembly 260. In FIG. 12, the housing 256 includes a first housing
portion 256A that is coupled to a second housing portion 256B to
facilitate assembling the actuator assembly 240; however, the
housing 256 can be integrally formed and/or include more than two
portions in other examples.
[0063] The actuator device 258 includes a plunger rod 262 for
engaging the stopper 222 in the container 220 when the actuator
assembly 240 is coupled to the container holder assembly 210. The
plunger rod 262 includes a proximal-most surface 262A for engaging
the stopper 222 such that axial movement of the plunger rod 262
causes corresponding axial movement of the stopper 222 within the
container 220. The actuator device 258 also includes a drive
mechanism (not shown) for axial moving the plunger rod 262
responsive to a user input on the actuator device 258 (e.g., via
one or more buttons).
[0064] The retainer assembly 260 facilitates positioning the
container 220 in a predetermined position within the container
holder assembly 210 and with respect to the plunger rod 262 when
the actuator assembly 240 is coupled with the container assembly
210. In particular, the retainer assembly 260 applies a proximally
directed biasing force to the container 220, which forces the
container 220 toward the proximal end 262B of the inner housing
262. Beneficially, the retainer assembly 260 thus allows for
relatively undesired tolerances in the physical dimensions of the
container 220 and/or container holder assembly 210 without
affecting the accuracy of the dose delivery (i.e., by holding the
container 220 in a fixed position in relation to the container
holder assembly 210, and without damaging the container 220).
[0065] As shown in FIG. 12, the retainer assembly 260 includes a
plunger lock 264, a retaining member 266, a biasing member 268, and
a supporting washer 270. A perspective view of the plunger lock 264
is depicted in FIG. 13. As shown in FIG. 13, the plunger lock 264
includes an internal cavity 272 defined by a side wall 274
extending from a proximal opening 276 to a distal opening 278 of
the plunger lock 264. Additionally, the plunger lock 264 includes
multiple apertures 280 in the side wall 274 of the plunger lock
264. The apertures 280 in the side wall 274 of the plunger lock 264
provide tracks 282 for guiding axial movement of the retaining
member 266 as described below.
[0066] As shown in FIGS. 8A-8B, the plunger lock 264 is fixedly
coupled to the housing 256 of the actuator assembly 240. In
particular, when the actuator assembly 240 is assembled, the
plunger lock 264 is seated within the proximal portion 228 of the
actuator assembly 240. As further shown in FIGS. 8A-8B, when the
actuator assembly 240 is assembled, the plunger rod 262 passes
through the axially aligned internal cavity 272 of the plunger lock
264. In this way, the plunger rod 262 is secured by the plunger
lock 264.
[0067] As shown in FIGS. 8A-8B and FIGS. 12-13, the plunger lock
264 also includes one or more retention members 286 extending
outwardly away from the side wall 274 of the plunger lock 264. The
retention members 286 engage with corresponding apertures 288 in
the housing 256 of the actuator assembly 240 to axially retain the
plunger lock 264 relative to the housing 256. In the illustrated
example, the apertures 288 in the housing 256 extend over a portion
of the circumference of the housing 256 to allow the plunger lock
264 to rotate within the housing 256. In other examples, the
plunger lock 264 can also be rotationally secured relative to the
housing 256.
[0068] FIGS. 14A-14B depict perspective views of the retaining
member 266 and FIG. 14C depicts a cross-sectional view of the
retaining member 266 taken through an axis 267 in FIG. 14A. As
shown in FIGS. 14A-14B, the retaining member 266 has an outer wall
304 that extends from a front end 266A to a back end 266B. The
outer wall 304 is generally cylindrical in FIGS. 14A-14C; however,
the outer wall 304 can have a different shape in other
examples.
[0069] On the outer wall 304, the retaining member 266 has a
plurality of spacer elements 290 equally spaced around a
circumference of the outer wall 304 at the back end 266B of the
retaining member 266. Each spacer element 290 is configured to
engage a respective one of the tracks 282 on the plunger lock 264
when the retaining member 266 is seated within the internal cavity
272 of the plunger lock 264. When the spacer elements 290 are
engaged with the tracks 282, the retaining member 266 can move
axially relative to the plunger lock 264 over a predetermined
distance corresponding to the length of the tracks 282. In the
illustrated example, the engagement between the spacer elements 290
and the tracks 282 can prevent rotational movement of the retaining
member 266 relative to the plunger lock 264. In other examples, the
spacer elements 290 and/or tracks 282 can be configured to permit
rotational movement of the retaining member 266 relative to the
plunger lock 264.
[0070] Also, as shown in FIGS. 14A-14C, the retaining member 266
includes an interior passage 292 that extends from a proximal
opening 294 at the front end 266A to a distal opening 296 at the
back end 266B. A first portion of the interior passage 292 extends
from the proximal opening 294 to a shoulder 298 and a second
portion of the interior passage 292 extends from the shoulder 298
to the distal opening 296. The shoulder 298 provides a first end
wall for engaging a distal end of the container 220 when the
container 220 is received in the first portion of the interior
passage 292. The second portion of the interior passage 292 is
configured to receive the plunger rod 262 such that plunger rod 262
can pass through the interior passage 292 and engage the moveable
stopper 222 in the container 220. As shown in FIG. 14C, the
interior passage 292 generally forms a cylinder in which the first
portion of the interior passage 292 has a diameter that is larger
than a diameter of the second portion of the interior passage
292.
[0071] At the back end 266B, the retaining member 266 further
includes a cavity 300 formed between an inner wall 302 and the
outer wall 304 of the retaining member 266. The cavity 300 extends
from an aperture in the back end 266B to a second end wall 306 in
the retaining member 266. The cavity 300 can be cylindrical and,
thus, the second end wall 306 can be an annular structure within
the retaining member 266. The cavity 300 and the interior passage
292 may also be co-axially aligned with each other. In other
examples, the inner wall 302, the outer wall 304, and the cavity
300 can be shaped differently.
[0072] FIG. 15 depicts a cross-sectional view of the proximal end
284 of the actuator assembly 240. As shown in FIG. 15, the cavity
300 receives a first end 268A of the biasing member 268 such that
the first end 268A of the biasing member 268 engages the second end
wall 306 of the cavity 300. A second end 268B of the biasing member
268 engages a front side 270A of the support washer 270. A back
side 270B of the support washer 270 engages a proximal portion of
the actuator device 258, inhibiting distal movement of the support
washer 270. The biasing member 268 is thus secured between the
retaining member 266 and a proximal portion of the actuator device
258. With the support washer 270 axially fixed, the biasing member
268 provides a proximally directed biasing force to the retaining
member 266 via the engagement between the biasing member 268 and
the second end wall 306. In turn, the retaining member 266 provides
the proximally directed biasing force to the container 220 when the
container 220 engages the shoulder 298 in the retaining member
266.
[0073] As described above, the medicament delivery device 200 is
assembled by inserting the container 220 into the bore 214 of the
container holder assembly 240. In an example, the container 220 has
a length that is generally greater than a length of the bore 214
and, thus, the distal end 218A of the container 220 can extend
distally from the distal end 238A of the inner housing 238 (as
shown in FIGS. 16A-16B).
[0074] Next, the container holder assembly 210 is coupled to the
actuator assembly 240. For instance, the protrusions 234 on the
inner surface 236 of the container holder assembly 210 can be
aligned with the tracks 230 on the exterior surface 226 of the
actuator assembly 240. FIG. 16A depicts a cross-sectional view of
the container 220 in the interior passage 292 of the retaining
member 266 while the container holder assembly 210 initially
engages the actuator assembly 240 (e.g., when the protrusion(s) 234
are initially received in the track(s) 230). As shown in FIG. 16A,
a distal end of the container 220 extends from the container holder
assembly 210 and is received in the first portion of the interior
passage 292 of the retaining member 266. In FIG. 16A, with the
container holder assembly 210 initially engaging the actuator
assembly 240, the container 220 does not yet contact the shoulder
298 in the retaining member 266. Further, the retaining member 266
is biased proximally by the biasing member 268 acting on the second
end wall 306 and the supporting washer 270; however, this biasing
force is not yet applied to the container 220 because the container
220 does not yet engage the retaining member 266. As described
above, the retaining member 266 is axially retained in the plunger
lock 264 by the spacer elements 290 of the retaining member 266
engaging the tracks 282 of the plunger lock 264.
[0075] The container holder assembly 210 can be further secured to
the actuator assembly 240 by rotating the container holder assembly
210 relative to the actuator assembly 240 until the protrusions 234
are fully seated in the tracks 230. FIG. 16B depicts a
cross-sectional view of the container 220 in the interior passage
292 of the retaining member 266 after the container holder assembly
210 has been completely coupled to the actuator assembly 240 (e.g.,
after the container holder assembly 210 has been rotated such that
the protrusion(s) 234 reach the end of the track(s) 230). As shown
in FIG. 16B, the distal end of the container 220 engages the
shoulder 298 of the retaining member 266, forcing the retaining
member 266 to an axial position that is distal of the axial
position of the retaining member 266 shown in FIG. 16A. Due to this
engagement, the retaining member 266 also applies the proximally
directed force of the biasing member 268 to the container 220 to
facilitate positioning the container 220 in a predetermined
position within the container holder assembly 210 (e.g., against
the shoulder portion 225 at the proximal end 218B of the container
220).
[0076] Further, as shown in FIG. 16B, the plunger rod 262 passes
through an aperture in the supporting washer 270, the internal
cavity 272 of the plunger lock 264, and the interior passage 292 of
the retaining member 266 to engage the movable stopper 222 in the
container 220. Additionally, as shown in FIG. 16B, the plunger lock
264 releasably engages the distal end of the container holder
assembly 210. In particular, the plunger lock 264 engages the
resilient structure 246 on the inner housing 238 of the container
holder assembly 210. Due to the resiliency of the resilient
structure 246, the inner housing 238 can absorb a proximal force
applied by the plunger lock 264 responsive to the container holder
assembly 210 coupling to the actuator assembly 240.
[0077] The present invention is not limited to the above-described
preferred embodiments. Various alternatives, modifications and
equivalents may be used. Therefore, the above embodiment should not
be taken as limiting the scope of the invention, which is defined
by the appended claims.
* * * * *